Long-term outcome of bipolar depressed patients receiving lamotrigine as add-on to lithium with the possibility of the addition of paroxetine in nonresponders: a randomized, placebo-controlled trial with a novel design

Authors


  • A full list of the LamLit Study Group appears before the references.

  • This study protocol is registered at: http://www.ClinicalTrials.gov: ClinicalTrials.gov Identifier: NCT00224510.

  • Disclosure information for all authors is listed before the references.

Corresponding author:
Marc L.M. van der Loos, M.D.
Department of Psychiatry
Isala Klinieken Lokatie Sophia
Dr. van Heesweg 2
Postbus 10400
8000 GK Zwolle, The Netherlands
Fax: +31384247620
E-mail: m.l.m.van.der.loos@isala.nl

Abstract

van der Loos MLM, Mulder P, Hartong EGThM, Blom MBJ, Vergouwen AC, van Noorden MS, Timmermans MA, Vieta E, Nolen WA, for the LamLit Study Group. Long-term outcome of bipolar depressed patients receiving lamotrigine as add-on to lithium with the possibility of the addition of paroxetine in nonresponders: a randomized, placebo-controlled trial with a novel design.
Bipolar Disord 2011: 13: 111–117. © 2011 The Authors.
Journal compilation © 2011 John Wiley & Sons A/S.

Objective:  In two previous manuscripts, we described the efficacy of lamotrigine versus placebo as add-on to lithium (followed by the addition of paroxetine in nonresponders) in the short-term treatment of bipolar depression. In this paper we describe the long-term (68 weeks) outcome of that study.

Methods:  A total of 124 bipolar depressed patients receiving lithium were randomized to addition of lamotrigine or placebo. After eight weeks, paroxetine was added to nonresponders for another eight weeks. Responders continued medication and were followed for up to 68 weeks or until a relapse or recurrence of a depressive or manic episode.

Results:  After eight weeks, the addition of lamotrigine to lithium was significantly more efficacious than addition of placebo, while after addition of paroxetine in nonresponders both groups further improved with no significant difference between groups at week 16. During follow-up the efficacy of lamotrigine was maintained: time to relapse or recurrence was longer for the lamotrigine group [median time 10.0 months (confidence interval: 1.1–18.8)] versus the placebo group [3.5 months (confidence interval: 0.7–7.0)].

Conclusion:  In patients with bipolar depression, despite continued use of lithium, addition of lamotrigine revealed a continued benefit compared to placebo throughout the entire study.

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